Section 122D(1) in The Drugs and Cosmetics Rules, 1945
(1)An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122-E shall be made to the licensing authority as defined in clause (b) of rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y.
